高效液相法测定氯尼达明的有关物质和含量  

High performance liquid chromatogaph determination of lonidamine＇s related substance and content

作　　者：金冲[1] 许宁[1] 陈景[1] 周国防[1] 焦小丽[1] 余晓燕[1] 

机构地区：[1]扬子江药业集团有限公司质管部,江苏省泰州市225321

出　　处：《中国医药》2010年第6期537-538,共2页China Medicine

摘　　要：目的 测定氯尼达明的有关物质和含量.方法 在系统适用性和专属性试验的基础上,采用反相色谱柱[Hypersil C18硅烷柱（ODS）（200×4.6 mm）]：流动相为甲醇-水-冰醋酸（80：11：1）;柱温为：25℃;流速为1.0 ml/min;检测波长为298 nm,建立测定氯尼达明有关物质和含量的高效液相色谱法.结果 氯尼达明在2～16μg/ml 浓度范围内与其峰面积呈线性关系,回归方程为A=7043C-108353,r=0.9914,测得的氯尼达明含量在98.5%以上,有关物质含量均小于1%.结论 高效液相色谱法测定氯尼达明的有关物质和含量方法准确、简便、可行,重现性和稳定性好,可适用于氯尼达明的含量测定及其有关物质检测.Objective To observe the impurities and assay of Lonidamine.Methods Based on the system suitability and specificity, a reversed-phase column [Hypersil C18 column silane （ODS） （200 × 4.6 mm）] and a methanol-water-glacial acetic acid （80： 11：1） mobile phase, Lonidamine＇s related substances and content were determined by HPLC with the column temperature 25℃, the flow rate 1.0 ml/min and the detection wave length 298 nm.Results Lonidamine is linear relationship with its peak area in in the concentration range of 2 ～ 16 μg/ml,its regression equation is A = 7043C-108353, r = 0.9914. All the contents were above 98.5%. Conclusion Determination of lonidamine related material and content by high performance liquid is accurate, simple, feasible,as well as of high reproducibility and stability.

关 键 词：高效液相 氯尼达明 含量测定 

分 类 号：R917[医药卫生—药物分析学]